Senior Manager, Supply Chain Quality Lead

Role Summary

The Senior Manager, Supply Chain Quality Lead will provide oversight and support to all distribution quality activities within the USA. This role will develop quality awareness across processes, mentor quality management systems, and liaise with functions within the Pharma Operations & Technology division to ensure seamless processes and patient access to medicines. QA oversight includes logistics of product distribution worldwide, deviations, CAPAs, Change Controls, audits, and serialization. This position is hybrid (3 days on-site) and can be located in Cambridge, MA or Research Triangle Park, NC.

Responsibilities

• Ensure quality and uninterrupted supply through quality measures across the supply chain and maintain compliant quality systems
• Approve shipping qualification for passive and active cooling in transportation; support ex-US internal logistics shipping qualification
• Ensure regulatory inspection readiness for distribution
• Oversee distribution-related procedures for the USA, including oversight of distribution partners
• Establish and maintain Quality Agreements to assure product quality and uninterrupted supply
• Hold regular Quality Management Reviews with distribution partners and monitor performance against KPIs
• Manage projects related to product distribution and quality standards/compliance improvements
• Support governance of Global Commercial Quality
• Manage processes related to suspect or illegitimate medicines, returns, and recalls
• Provide quality support for pipeline growth and continuous product supply
• Participate in new product launch planning to identify required quality actions
• Other duties as assigned

Qualifications

• Required: Bachelor's Degree in life sciences, supply chain, or related field
• Required: Minimum of 7 years of GMP and/or GDP experience for medicinal/pharmaceutical products within a Quality Assurance logistics environment
• Required: Quality and distribution expertise, including cold chain and deep frozen products
• Required: Outstanding communication skills, including delegation, influencing, stakeholder management, and networking
• Required: Ability to work independently to drive projects to completion
• Required: Vendor management experience
• Required: Demonstrated experience resolving distribution issues impacting medicinal products
• Preferred: Experience supporting global teams across multiple time zones

Skills

• Quality Assurance in a pharmaceutical logistics environment
• Regulatory compliance and inspection readiness
• Quality agreements and vendor relationship management
• Project management and problem-solving
• Cross-functional collaboration and global team coordination

Education

• Bachelor's Degree required; preferred in life sciences, supply chain, or related field